(70 days)
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No
The device description and performance studies focus on a rapid immuno-chromatographic test using antibodies and visual interpretation of lines, with no mention of AI or ML technologies. The performance study even notes that agreement of positive results is "mainly explained by the human reading of the device."
No.
The device is described as an immunoassay for the detection of IgE in tears, intended for diagnostic purposes to identify allergic conjunctivitis, not for treating a condition.
Yes
The device detects total IgE in tears to indicate local IgE production associated with allergic conjunctivitis, which falls under the definition of diagnosis.
No
The device description clearly states it is a "ready-to-use strip" and an "immuno-chromatographic test," indicating it is a physical test strip with incorporated reagents, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "rapid immunoassay for the detection of total IgE in tears" and "indicates local IgE production associated with allergic conjunctivitis." This is a diagnostic purpose, aiming to identify a medical condition.
- Sample Type: The test analyzes "tears," which are a biological sample taken from the human body.
- Method: It uses an "immuno-chromatographic test" with "monoclonal and polyclonal antibodies to detect total IgE." This is a common method used in IVD tests to detect specific substances in biological samples.
- Purpose: The test is used "in the physician office and professional clinical laboratories" to aid in the diagnosis of allergic conjunctivitis.
While the device description mentions it can be done "in vivo without being invasive" by placing the strip in contact with the eye, the core of the test is the analysis of the tear fluid absorbed onto the strip. The chemical reaction and detection of IgE happen in vitro on the strip itself, using the collected tear sample. The "in vivo" aspect refers to the method of sample collection, not the diagnostic process itself.
Therefore, the primary function of the device is to perform a diagnostic test on a biological sample (tears) outside of the body, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lacrytest is a rapid immunoassay for the detection ר্তা total IgE in tears, Semi-quantitative detection of total IgE In tears ( 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.
Product codes (comma separated list FDA assigned to the subject device)
DGC
Device Description
Lacrytest, a simple and rapid immuno-chromatographic test, enables the identification of allergic conjunctivitis in one single step. The speed and simplicity of this unique test enables better and faster care and treatment of the patient.
Lacrytest is a ready-to-use strip, with all the necessary reagents already incorporated into it. No instrumentation or prior provision of tear samples is required: Lacrytest uses monoclonal and polyclonal antibodies to detect total IgE in tears. Lacrytest gives results from just one teardrop, and is placed in contact with the patient's eye for less than three minutes, causing minimum discomfort when compared to the Schirmer assay. Doctors do not have to take tear sample, and an indicator appears on the strip when enough tear fluid has been absorbed. The test strip is then soaked with sterile water and the evaluation of amount of total IgE detected.
The results appear in the form of easily visible red-violet lines in the presence of total IgE levels greater than 2,5 KUI/L (the detection limit). These results are stable and can be archived. The test can be used in the laboratory, in the doctor's surgery or on a home visit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
tears
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician office and professional clinical laboratories. It can also be used in the doctor’s surgery or on a home visit.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative studies, carried out on 165 human serums with reference to the UniCAP.
No significant differences occurred between the different sites regarding the negative samples, when comparing results obtained by professional Lab technicians with persons at the point of care facilities. Some differences, mainly an upper estimation of the IgE levels, have been observed concerning the agreement of IgE concentration categories.
87% of normal healthy subjects give a Lacrytest response negative, i.e. less than 2,5 kIU/l. 13% of normal healthy subjects give an Intensity 1 Lacrytest results (low positive).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 91.7%
Specificity: 98.5%
Agreement of negative results: 87.79%
Agreement of positive results: 84.21%
Accuracy determination of semi-quantitative results: 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
MAR - 9 2004
SECTION 7
Premarket notification summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 21 CFR 807.92
The assigned 510(k) number is:
Date of summary preparation: Submitter's name: Address:
Phone: Fax : Contact : Device name: Trade name: Classification name:
July 15 2002 Mr. Joël Lesser 1 Place Alexis Ricordeau 44 093 NANTES Cedex 1 FRANCE 33 (0)2 51 72 11 40 33 (0)2 51 72 37 73 Mr. Joël Lesser Lacrytest
Lacrytest Immunological test
7- PREMARKET NOTIFICATION 510(K) SUMMARY. .
7-1 Predicate device.
| Device Classification Name | IGE, ANTIGEN, ANTISERUM,
CONTROL |
|----------------------------|----------------------------------------------------------|
| Regulation Number | 866.5510 |
| 510(K) Number | K964152 |
| Device Name | UNICAP TOTAL IGE
ASSAY/PHARMACIA TOTAL IGE
CONTROL |
1
ADIATEC SA Company asserts that the UniCAP total IgE FEIA Assay is substantially equivalent to the Lacrytest. Each product is designed to measure the level of total IgE. Each product is an Immuno Assay.
7-2 Intended use.
Lacrytest is a rapid immunoassay for the total IgE detection in tears. Normal values are below 2,5 kUI/l, (3 ng/ml). This assay indicates in a qualitative way the presence of total class E immunoglobulins in tears, with level above normal value.
Lacrytest offers help for ocular allergy diagnosis in a simple and fast way.
Lacrytest is to be used with IgE mediated allergic ocular disorders.
It allows knowing if an ocular inflammation, conjunctivitis, or dry eyes symptom could be linked to allergic ocular disorder.
This test is dedicated to the physicians and clinical Laboratory.
7-3 General description
LACRYTEST (marked CE) allows the rapid and specific determination of total IgE in tears (in vivo/in vitro).
This test is a simple and rapid immuno-chromatographic test, which enables the identification of allergic conjunctivitis in one single step. Its main advantage is that it can be done in vivo without being invasive. The speed and simplicity of this unique test enables a better and faster treatment of the patient.
7-4 Description of the device.
Lacrytest, a simple and rapid immuno-chromatographic test, enables the identification of allergic conjunctivitis in one single step. The speed and simplicity of this unique test enables better and faster care and treatment of the patient.
Lacrytest is a ready-to-use strip, with all the necessary reagents already incorporated into it. No instrumentation or prior provision of tear samples is required: Lacrytest uses monoclonal and polyclonal antibodies to detect total IgE in tears. Lacrytest gives results from just one teardrop, and is placed in contact with the patient's eye for less than three minutes, causing minimum discomfort when compared to the Schirmer assay. Doctors do not have to take tear sample, and an indicator appears on the strip when enough tear fluid has been absorbed. The test strip is then soaked with sterile water and the evaluation of amount of total IgE detected.
The results appear in the form of easily visible red-violet lines in the presence of total IgE levels greater than 2,5 KUI/L (the detection limit). These results are stable and can be archived. The test can be used in the laboratory, in the doctor's surgery or on a home visit.
2
7-5 Qualitative constitution of the reagent:
Chemical products:
- · trihydrated tetrachloroauric acid (III): HAu Cl4 3H20
- · Natrium Azide: NaN3
- · Polyethylen glycol 20000: HO (C2H4O)n H
- · Hydrolyzed Polyvinyl Alcohol, 80%
- · Sucrose 98%: D(+) saccharose
- · Thimérosal to 0,001%
Materials:
- · Nitrocellulose
- · Polyester resin fibers,
- · Cellulose,
- · Adhesive band
- · The band in contact with the eye is a membrane constituted of polyester fibers and a surfactant. Those two components, "Pall Profile Filter" and "Bioinert Filter", are unprovided with toxicity as specified in the toxicity tests certificates enclosed in the annex.
Biological products:
- · Monoclonal Antibodies and mouse and goat polyclonal antibodies, purified with affinity chromatography, specific of type E human immunoglobulins (hIgE) and type G.mouse immunoglobulins
- · Cream milk Gloria Nestlé
- · Purified Bovine Serum Albumin: animal origin
7- 6 Performance equivalence: Technology comparison.
uses the ELISA method whereas ADIATEC develops immuno-UniCAP chromatographic assay. UniCAP can give total IgE levels accurate measurement and uses 48 different parameters.
Lacrytest is a ready-to-use strip, with all the necessary reagents already incorporated into it. No instrumentation or prior provision of tear is necessary. The total IgE level is given on the strip.
Contrary to that, UniCAP needs blood sampling and so human serum, or a high volume of tears. The results are given with UniCAP 100 Instrument which is programmed to automatically calculate data from UniCAP total IgE assay. The total IgE values for controls and patient samples are automatically calculated and printed out
- Like the LACRYTEST, UniCAP total IgE Assay is an in vitro Assay for the measurement of total IgE. An other common point is the fact that the both devices are to be used in clinical laboratories.
3
But contrary to UniCAP, Lacrytest is furthermore to be used in medical offices.
7-7 Performance Equivalence-method comparison.
-
Comparative studies, carried out on 165 human serums with reference to the UniCAP, have shown that it has a sensitivity of 91.7% and a specificity of 98.5%.
-
We can make a parallel between the precision of the Lacrytest and the precision of the UniCAP:
| Precision. Lacrylest | |||||
|---|---|---|---|---|---|
| Intra-run | LO | ||||
| Ll | 12 | ﺩ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ | |||
| Number of determinations | 30 | 30 | 30 | 30 | |
| Total IgE levels KUI/L | 0 | 20 | 50 | ||
| Ranges (intensities) | 0 | 0 - 1 2 - 3 | 4 | ||
| Mean value (intensity) | 0 | ||||
| Variance % | O | ||||
| Inter-run | L0 | L1 | L2 | L3 | |
| Number of determinations | 20 | 20 | 20 | 20 | |
| Total IgE levels KUI/L | 0 | 5 | 20 | 50 | |
| Ranges (intensities) | 0 | 0 - 1 | 2 - 3 | 3 - 3 | |
| Mean value (intensity) | 0 | 1 | 2 | 3 | |
| Variance % | 0 | 10 | 4 | 0 |
Procision: I acruast
Precision: UniCAP
| Serum level | Coefficients of variation (%) | |
|---|---|---|
| KIU/I | Within assay | Between |
| 13 | 2.8 | 8.9 |
| 75 | 2.0 | 5.3 |
| 640 | 2.8 | 9.1 |
The coefficient of variation of UniCAP is similar at low levels (13 kIU/l) than high levels. Lacrytest has a higher coefficient of variation for low levels (5 kIU/l), but its coefficient of variation is similar for level of 20 kIU/1.
- We can make a parallel between the sensitivity and specificity of the Lacrytest and those of the UniCAP:
Lacrytest has a detection limit of 2,5 kFU/1 and the UniCAP detection limit is 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ia chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K034057
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